MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG; SYRINGE, ANTISTICK

Catalog Number 305937

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 0.3ml 31ga tw 8mm bls 400 sg was unable to deliver medication.This was discovered during use.The following information was provided by the initial reporter: obstruction.Can¿t extract medicine.

Event Description

It was reported that syringe 0.3ml 31ga tw 8mm bls 400 sg was unable to deliver medication.This was discovered during use.The following information was provided by the initial reporter: obstruction.Can¿t extract medicine.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/30/2020.H.6.Investigation: customer returned (1) 3/10cc, 8mm, 31g bd safetygglide insulin syringe in an open blister pack from lot # 8325571.Customer states that there is an obstruction and they can¿t extract the medicine.The returned syringe was tested and was not able to draw properly.The sample was then wired and the wire was not able to pass through the cannula, indicating that there is an adhesive clog in the cannula.A review of the device history record was completed for batch# 8325571.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200791593, 200791313] noted that did not pertain to the complaint.Process: the racks carrying the hub with cannula move further down along a rail, a pullout device moves the cannula out a small distance for adhesive to be applied.During the parts pass under the corona treater pins and exposed to an ion rich corona field, which increases surface energy wettability to aid in the adhesion of the adhesive to the hub.The cannula is then re-inserted into the hub with vacuum.The pim inspection systems looks for adhesive clogs and rejects the needle assemblies in the process.Investigation: a review of the device history record was completed for batch# 8325571.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200791593, 200791313] noted that did not pertain to the complaint.Root cause: root cause cannot be determined for this complaint.

• Brand Name: SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10209737
• MDR Text Key: 198081779
• Report Number: 1920898-2020-00764
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 305937
• Device Lot Number: 8325571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other